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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K911269
Device Name MERCURY AND GLASS FEVER THERMOMETER
Applicant
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Applicant Contact MARK P PONCY
Correspondent
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Correspondent Contact MARK P PONCY
Regulation Number880.2920
Classification Product Code
FLK  
Date Received03/22/1991
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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